Version May 2024
Effective June 28, 2023, the FDA has withdrawn approval of the new drug application for Oxandrin (oxandrolone) held by Gemini Laboratories and the abbreviated new drug applications for oxandrolone from Upsher-Smith Laboratories, Par Pharmaceutical, and Sandoz. Multiple safety warnings and precautions are associated with the use of oxandrolone, including peliosis hepatis, sometimes associated with liver failure and intra-abdominal hemorrhage; liver cell tumors, sometimes fatal; and blood lipid changes that are known to be associated with increased risk of atherosclerosis. Additional warnings include the risks associated with cholestatic hepatitis, hypercalcemia in patients with breast cancer, and increased risk for the development of prostatic hypertrophy and prostatic carcinoma in older patients. Based on the available data, the FDA concluded that oxandrolone should be removed from the market. Distribution into interstate commerce without an approved application is illegal and subject to regulatory action.
Further information is available at https://www.federalregister.gov/documents/2023/06/28/2023-13733/gemini-laboratories-llc-et-al-withdrawal-of-approval-of-one-new-drug-application-for-oxandrin.
Peliosis hepatis, a condition in which liver and, sometimes, splenic tissue is replaced with blood-filled cysts, has occurred in patients receiving androgenic anabolic steroids. These cysts are sometimes present with minimal hepatic dysfunction and have been associated with liver failure. Often, they are not recognized until life-threatening liver failure or intra-abdominal hemorrhage develops. Withdrawal of drug usually results in complete disappearance of lesions.
Most often these tumors are benign and androgen-dependent, but fatal malignant tumors have occurred. Withdrawal of drug often results in regression or cessation of tumor progression. However, hepatic tumors associated with androgens or anabolic steroids are much more vascular than other hepatic tumors and may be silent until life-threatening, intra-abdominal hemorrhage develops.
Blood lipid changes associated with increased risk of atherosclerosis are seen in patients treated with androgens and anabolic steroids. These changes include decreased high-density lipoprotein (HDL) and, sometimes, increased low-density lipoprotein (LDL). The changes may be very marked and could have a serious impact on the risk of atherosclerosis and coronary artery disease.
Note: Effective June 28, 2023, the FDA has withdrawn approval of the new drug application for oxandrolone for all indications. Distribution into interstate commerce without an approved application is illegal and subject to regulatory action.
Burns, moderate to severe (adjunctive agent) (off-label use): Oral: 10 mg every 12 hours; generally start within the first ~7 days following injury (Ref).
Osteoporosis-associated bone pain (adjunctive agent):
Note: Available data to support use in this condition are limited. Current guidelines for the treatment of osteoporosis do not include recommendations for the use of oxandrolone for this purpose (Ref).
Oral: 2.5 to 20 mg/day in 2 to 4 divided doses based on individual response; a course of therapy of 2 to 4 weeks is usually adequate. May repeat intermittently as needed.
Protein catabolism, corticosteroid-induced (adjunctive agent):
Note: Available data to support use for this purpose are limited.
Oral: 2.5 to 20 mg/day in 2 to 4 divided doses based on individual response; a course of therapy of 2 to 4 weeks is usually adequate. May repeat intermittently as needed.
Weight gain (adjunctive agent ):
Note: Studies of oxandrolone in patients with weight loss associated with HIV/AIDS and chronic obstructive pulmonary disease have not consistently shown improvement in functional status or quality of life and many did not include females (Ref).
Oral: 2.5 to 20 mg/day in 2 to 4 divided doses based on individual response; a course of therapy of 2 to 4 weeks is usually adequate. May repeat intermittently as needed.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling; use with caution due to propensity to cause edema.
Preexisting impairment: There are no dosage adjustments provided in the manufacturer's labeling; use with caution.
Hepatotoxicity during therapy: Discontinue use if abnormal LFTs or cholestatic hepatitis with jaundice occurs; changes in LFTs and drug-induced jaundice are reversible upon discontinuation.
Weight gain (adjunctive agent):
Note: The American Geriatrics Society recommends avoiding prescription appetite stimulants (including anabolic steroids) for treatment of anorexia and cachexia in older adults (Ref).
Oral: 5 mg twice daily.
(For additional information see "Oxandrolone (United States: FDA approval withdrawn): Pediatric drug information")
Note: Effective June 28, 2023, the FDA has withdrawn approval of the new drug application for oxandrolone for all indications. Distribution into interstate commerce without an approved application is illegal and subject to regulatory action.
Burn management, severe; to increase lean muscle mass and promote wound healing: Limited data available: Children and Adolescents: Oral: 0.1 mg/kg/dose twice daily for up to 12 months has been shown to increase lean body mass, bone mineral density, and muscle strength; shortened length of ICU stay and improved donor site wound healing were also observed (Ref). Benefits have been shown to persist for up to 5 years post burn (Ref).
Constitutional delay of growth and puberty (CDGP) (males): Limited data available: Children and Adolescents 9 to 16 years: Oral: 1.25 to 2.5 mg once daily in the evening; usual duration: 3 to 12 months although longer (~5 years) has been reported (Ref)
Turner syndrome (females): Limited data available: Children and Adolescents ≥8 years: Oral: Reported range: 0.03 to 0.06 mg/kg/day at bedtime in combination with growth hormone and/or estrogen; maximum single dose: 2.5 mg/dose; due to risks of dose-related virilization, doses ≥0.05 mg/kg/day should generally be avoided. Typically, therapy initiated at 8 to 9 years of age and continued until goal height attained or further growth is unlikely (eg, bone age ≥14 years and growth velocity <2 cm/year) (Ref).
Weight gain, adjunct: Children and Adolescents: Oral: Total daily dose: ≤0.1 mg/kg; may be repeated intermittently as needed; in adult patients, the daily dose is divided 2 to 4 times daily; typical duration of therapy: 2 to 4 weeks
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
All patients: There are no dosage adjustments provided in the manufacturer's labeling. Caution is recommended because of the propensity of oxandrolone to cause edema and water retention.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Frequency not defined:
Cardiovascular: Edema
Central nervous system: Deepening of the voice (females), depression, excitement, habituation, insomnia
Dermatologic: Acne vulgaris (females and prepubertal males), androgenetic alopecia (females)
Endocrine & metabolic: Changes in libido, decreased glucose tolerance, decreased HDL cholesterol, electrolyte disturbance, gynecomastia, hirsutism (females), increased LDL cholesterol, inhibition of gonadotropin secretion, menstrual disease (females)
Genitourinary: Clitoromegaly (females), epididymitis (postpubertal males), erectile dysfunction (prepubertal males; increased or persistent erections), impotence (postpubertal males), inhibition of testicular function (postpubertal males), irritable bladder (postpubertal males), oligospermia (postpubertal males), phallic enlargement (prepubertal males), priapism (chronic; postpubertal males), testicular atrophy (postpubertal males)
Hematologic & oncologic: Clotting factors suppression, prolonged prothrombin time
Hepatic: Cholestatic jaundice, hepatocellular neoplasm, increased serum alkaline phosphatase, increased serum ALT, increased serum AST, increased serum bilirubin, peliosis hepatitis (long-term therapy)
Neuromuscular & skeletal: Increased creatine phosphokinase, premature epiphyseal closure (children)
Renal: Increased creatinine clearance
<1%, postmarketing, and/or case reports: Hepatic necrosis, hepatotoxicity (idiosyncratic; Chalasani 2014)
Nephrosis; breast cancer in females with hypercalcemia; known or suspected prostate or breast cancer in males; hypercalcemia; pregnancy
Concerns related to adverse effects:
• Blood lipid changes: Use caution in patients at risk for, or with a history of cardiovascular disease; monitor lipid profile and adjust therapy as indicated. Lipid changes are usually reversible upon discontinuation of therapy.
• Gynecomastia: May cause gynecomastia.
• Oligospermia: May suppress spermatogenesis; oligospermia may occur.
• Polycythemia: Increased hemoglobin and hematocrit may occur with high doses of anabolic steroids.
• Priapism: Priapism or excessive sexual stimulation may occur.
Disease-related concerns:
• Breast cancer: Use with caution in females with breast cancer; may cause hypercalcemia by stimulating osteolysis; use is contraindicated in females with breast cancer and hypercalcemia. Discontinue use if hypercalcemia occurs.
• Carbohydrate intolerance: May have adverse effects on glucose tolerance; use caution in patients with diabetes.
• COPD: Use with caution in patients with COPD.
• Edematous conditions: Use with caution in patients with conditions influenced by edema (eg, cardiovascular disease, migraine, seizure disorder, hepatic impairment, renal impairment); may cause fluid retention.
Special populations:
• Older adult: Use with caution in older adults; older males may be at greater risk for prostatic hyperplasia and prostate cancer.
• Pediatric: May accelerate bone maturation without producing compensatory gain in linear growth in children; effect may continue for 6 months after the drug is stopped; in prepubertal children perform radiographic examination of the left hand and wrist every 6 months to determine the rate of bone maturation and to assess the effect of treatment on the epiphyseal centers.
• Females: May cause mild virilization in females. Discontinue with evidence of mild virilization in female patients; early discontinuation may prevent irreversible virilization.
Effective June 28, 2023, the FDA has withdrawn approval of the new drug application for oxandrolone for all indications. Distribution into interstate commerce without an approved application is illegal and subject to regulatory action. Further information is available at https://www.federalregister.gov/documents/2023/06/28/2023-13733/gemini-laboratories-llc-et-al-withdrawal-of-approval-of-one-new-drug-application-for-oxandrin.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Tablet, Oral:
Generic: 2.5 mg [DSC], 10 mg [DSC]
Yes
Tablets (Oxandrolone Oral)
2.5 mg (per each): $5.53
10 mg (per each): $18.75
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
C-III
Enteral feeding tube (off label): In severe burn patients unable to tolerate oral administration, oxandrolone may be extemporaneously prepared and administered via enteral feeding tube (Ref).
Oral: For patients unable to swallow tablets, an oral suspension may be extemporaneously prepared (see Extemporaneous Preparations for additional information). In adults (severe burn), oxandrolone tablets were dissolved in ethanol and administered through enteral feeding tube (Ref); pediatric experience has not been reported.
Note: Effective June 28, 2023, the FDA has withdrawn approval of the new drug application for oxandrolone for all indications. Distribution into interstate commerce without an approved application is illegal and subject to regulatory action.
Osteoporosis-associated bone pain: Relief of bone pain associated with osteoporosis.
Protein catabolism, corticosteroid-induced: Adjunctive therapy to offset protein catabolism associated with prolonged corticosteroid administration.
Weight gain: Adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infections, or severe trauma, and in some patients who, without definite pathophysiologic reasons, fail to gain or to maintain normal weight.
Burns, moderate to severe (adjunctive agent)
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs that have a heightened risk of causing significant patient harm when used in error.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Agents with Blood Glucose Lowering Effects: Androgens may enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Ajmaline: Androgens may enhance the adverse/toxic effect of Ajmaline. Specifically, the risk for cholestasis may be increased. Risk C: Monitor therapy
C1 inhibitors: Androgens may enhance the thrombogenic effect of C1 inhibitors. Risk C: Monitor therapy
Corticosteroids (Systemic): May enhance the fluid-retaining effect of Androgens. Risk C: Monitor therapy
CycloSPORINE (Systemic): Androgens may enhance the hepatotoxic effect of CycloSPORINE (Systemic). Androgens may increase the serum concentration of CycloSPORINE (Systemic). Management: Consider avoiding concomitant use of androgens and cyclosporine. If concomitant use is unavoidable, monitor serum cyclosporine concentrations and for signs and symptoms of hepatotoxicity. Cyclosporine dose reductions may be required. Risk D: Consider therapy modification
Hypertension-Associated Agents: May enhance the hypertensive effect of Androgens. Risk C: Monitor therapy
Vitamin K Antagonists (eg, warfarin): Androgens may enhance the anticoagulant effect of Vitamin K Antagonists. Management: Monitor for increased effects of vitamin K antagonists if an androgen is initiated/dose increased, or decreased effects if androgen is discontinued/dose decreased. Significant reductions in vitamin K antagonist dose are likely required. Risk D: Consider therapy modification
Use is contraindicated in pregnant women; masculinization of the fetus has been reported.
It is not known if oxandrolone is excreted in breast milk. Due to the potential for serious adverse reactions in the nursing infant, breastfeeding is not recommended.
LFTs (AST, ALT, bilirubin), cholesterol profile, hemoglobin/hematocrit; INR/PT in patients on anticoagulant therapy.
Children: Radiographs of left wrist and hand every 6 months (to assess bone maturation).
Adult females: Signs of virilization (deepening voice, hirsutism, acne, clitoromegaly); urine and serum calcium in females with breast cancer.
Synthetic testosterone derivative with similar androgenic and anabolic actions
Absorption: Oral: Well absorbed (Orr 2004)
Protein binding: 95% (Orr 2004)
Half-life elimination: 10 to 13 hours
Time to peak serum concentration: ~1 hour (Orr 2004)
Excretion: Urine (28% as unchanged drug) (Orr 2004)
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